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Sponsored by: |
Seattle Genetics, Inc. |
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Information provided by: | Seattle Genetics, Inc. |
ClinicalTrials.gov Identifier: | NCT00031187 |
SGN-15 is being investigated for therapy of patients with prostate cancer in combination with the cytotoxic agent, Taxotere. The study is an open label, randomized phase II study for patients with documented hormone refractory prostate cancer who have not had any prior therapy with Taxotere or Novantrone. Both SGN-15 and Taxotere will be administered weekly over two 6 week courses separated by a 2 week rest period.
Condition | Intervention | Phase |
---|---|---|
Prostatic Neoplasms |
Drug: SGN-15 (cBR96-doxorubicin immunoconjugate) Drug: Taxotere (docetaxel) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Taxotere in Patients With Hormone Refractory Prostate Carcinoma |
Estimated Enrollment: | 160 |
Study Start Date: | October 2000 |
The purpose of this study is to evaluate a new class of biologic agent, the monoclonal antibody (mAb) drug conjugate SGN-15 (cBR96 - Doxorubicin immunoconjugate), used in combination with the taxane agent, TAXOTERE (docetaxel) as a strategy for targeting advanced stage, hormone refractory prostate carcinoma (HRPC). This is a randomized, open label, phase II study evaluating the immunoconjugate SGN-15 in combination with the taxane TAXOTERE in comparison to TAXOTERE alone in patients with HRPC. Based on a previous phase I study of the SGN-15/TAXOTERE combination, the weekly dose of SGN-15 will be 200 mg/m2 and the weekly dose of TAXOTERE will be 35 mg/m2. The schedule of administration for both agents will be weekly, with SGN-15 administered prior to the TAXOTERE in the patients treated with the combination. A single course of therapy will be defined as 6 weekly doses followed by a 2 week rest period for a total of 8 weeks. The study will perform an interim analysis of the data after 80 patients have completed two courses. Patients should be treated for a minimum of 2 courses of therapy. Additionally, for patients who remain eligible and have experienced tolerable levels of drug toxicity, repeat dosing with subsequent cycles is possible. Patients will be removed from study if there is evidence of tumor progression or intolerable toxicity. Follow-up assessments include adverse event reporting, clinical laboratory studies, and quality of life (QOL) assessment using a validated QOL instrument.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
BRIEF:
Patients must have pathologically confirmed prostate cancer, which is refractory to hormone therapy. There must be evidence of advancing disease, determined by increasing bidimensional or unidimensional measurable tumor or an increasing PSA with documented metastatic disease.
Patients must have Lewis(Y) antigen expression documented by immunohistochemistry on archived or fresh tumor specimen.
United States, Arizona | |
Arizona Cancer Center | |
Tucson, Arizona, United States, 85724 | |
United States, Arkansas | |
Highlands Oncology Group | |
Springdale, Arkansas, United States, 72764 | |
United States, California | |
VA Medical Center of Palo Alto | |
Palo Alto, California, United States, 94304 | |
Sharp HealthCare, Sidney Kimmel Cancer Center | |
San Diego, California, United States, 92121 | |
West Los Angeles - VA Healthcare Center | |
Los Angeles, California, United States, 90073 | |
United States, Connecticut | |
Bendheim Cancer Center | |
Greenwich, Connecticut, United States, 06830 | |
United States, Florida | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33901 | |
Innovative Medical Research of South Florida | |
Miami Shores, Florida, United States, 33138 | |
Broward Oncology Associates | |
Ft. Lauderdale, Florida, United States, 33308 | |
United States, Michigan | |
St. Joseph Mercy Oakland Hospital | |
Pontiac, Michigan, United States, 33308 | |
United States, Virginia | |
Arlington Fairfax Hematology-Oncology, P.C. | |
Arlington, Virginia, United States, 22205 |
Study Director: | Andrew Sandler, MD | Seattle Genetics, Inc. |
Study ID Numbers: | SG0001-015 |
Study First Received: | February 27, 2002 |
Last Updated: | June 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00031187 |
Health Authority: | United States: Food and Drug Administration |
Prostate Lewis Blood-Group System Antibodies, Monoclonal Antigens, Neoplasm Antineoplastic Agents |
Antibodies, Monoclonal Docetaxel Antibodies Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Immunoconjugates Doxorubicin Immunoglobulins Carcinoma |
Neoplasms Neoplasms by Site Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Pharmacologic Actions |